Encore Medical djosurgical Instrucciones De Uso

DJO Surgical Instruments and Instrument Cases
Instrumente und Instrumentenbehälter von DJO Surgical
Instruments chirurgicaux et boîtiers à instruments DJO Surgical
Instrumentos y estuches de instrumentos quirúrgicos de DJO Surgical
Strumenti chirurgici e custodie DJO Surgical
Χεηξνπξγηθά όξγαλα θαη ζήθεο νξγάλσλ DJO Surgical
DJO Surgical Aletleri ve Alet Kutuları
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Encore Medical, L.P.
9800 Metric Blvd.
Austin, TX 78758
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
Distributed in Turkey by:
EndoProtez Ortopedi Ltd.Şti.
Halk Sokak ¼ Sıhhiye Ankara Türkiye
Telefon + 90 (312) 435 74 46
0400-0146 Rev. I 2011-10
EN
REUSABLE INSTRUMENT
DESCRIPTION
WARNINGS
CAUTION
REPROCESSING LIMITATIONS
DISCLAIMER
For cleaning and sterilization of instrumentation distributed by DJO Surgical, please refer to the manufacturer's Instructions for Use provided in the Instrument Tray.
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POINT OF USE PREPARATION
DISINFECTION
AUTOMATED CLEANING
DJO Surgical instrumentation consists of devices and their accessories used in surgical procedures. Implantation of DJO Surgical products should only
be performed with DJO Surgical instrumentation or instrumentation distributed by DJO Surgical.
generally composed of titanium, stainless steel, aluminum, and/or polymeric materials. The cases may be multi-layered with various inserts to hold surgical
instrumentation in place during handling and storage. The inserts may consist of trays, holders, and silicone mats. The instrument cases will allow
sterilization of the contents to occur in a steam autoclave utilizing the cleaning, sterilization, and drying cycle that has been validated and detailed below.
Instrument cases do not provide a sterile barrier and must be used in conjunction with sterilization wrap to maintain sterility. Instruments are provided
non-sterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below.
Automated cleaning may not be thorough enough. Carefully inspect each instrument to ensure that all visible blood residue and other contaminants have
been removed.
Federal Law (USA) restricts this device to sale by or on the order of a physician.
DJO Surgical instruments can be steam sterilized and repeat sterilization will not adversely affect them. If problems related to instrument sets are identified
when using our instruments or instrument cases, please bring it to the attention of DJO Surgical for investigation. The lifetime of an instrument is typically
limited by normal wear and damage due to use.
DJO Surgical instrument cases are intended to protect instrumentation and facilitate the sterilization process by allowing steam penetration and drying. DJO
Surgical has verified through laboratory testing that our instrument cases are suitable for the sterilization cycles listed in the sterilization section of the IFU.
Health care personnel are ultimately responsible for ensuring that any packaging method or material, including a reusable rigid container system, is suitable
for use in sterilization processing and sterility maintenance in their particular health care facility. Testing should be conducted in a health care facility to
assure that conditions essential to sterilization can be achieved.
Keep instruments moist and do not allow blood and/or bodily fluids to dry on the instruments. The decontamination process should begin immediately after
the completion of the surgical procedure. If cleaning must be delayed, place instruments in a covered container with appropriate enzymatic detergent to
delay drying. Instruments should be cleaned within 30 minutes of use to minimize the potential for drying prior to cleaning.
Wash all instruments whether or not they were used or were inadvertently contacted with blood. Disassemble instruments with removable parts; loosen
instruments with movable parts, as applicable.
Saturate the surface completely with full strength disinfectant/cleaner* (e.g. CaviCide) and allow to remain in contact with devices for 5 minutes.
DJO Surgical rigid instrument cases may be washed and/or disinfected by using an automated washer-disinfection unit utilizing thermal disinfection.
Temperatures, cycles, and disinfectant type used should be as instructed by manufacturer of the washer-disinfection unit. For ultrasonic cleaning follow the
manufacturer's specifications for suggested water level and concentration. When using mechanical washers, make sure the instruments are secured
in place, and do not touch or overlap. Automated washer/disinfector systems are not recommended as the sole cleaning method for complex, surgical
instruments. Complex instrumentation should be cleaned in accordance with the procedure described in the manual cleaning section.
Recommendation for the Care and Handling for
DJO Surgical Instruments and Instrument Cases
INSTRUCTIONS FOR USE
DJO Surgical instruments and instrument cases are
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